ROSA Knee System with UltraSound Imaging Platform (USIP)— 510(k) K252058

Substantially Equivalent

Balmoral Medical, LLC

FDA 510(k) clearance K252058 for ROSA Knee System with UltraSound Imaging Platform (USIP), Substantially Equivalent on 2026-02-06. Applicant: Balmoral Medical, LLC.

Clearance details

Applicant: Balmoral Medical, LLC
Product code: Code OLO
Advisory panel: Neurology
Date received: 2025-07-01
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosemont, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.